USPTO Patents Application 09446783

United States Patent and Trademark Office

UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450

Alexandria, Virginia 223 1 3- 1 450
www.uspto.gov

APPLICATION NO.

FILING DATE

FIRST NAMED INVENTOR

ATTORNEY DOCKET NO.

CONFIRMATION NO.

09/446,783

05/16/2000

30542 7590 07/12/2005

FOLEY & LARDNER

P.O. BOX 80278

SAN DIEGO, CA 92138-0278

NEIL P. DESAI

VPHAR1460-2

2878

EXAMINER

HARTLEY, MICHAEL G

ART UNIT

PAPER NUMBER

1618

DATE MAILED: 07/12/2005

Please find below and/or attached an Office communication concerning this application or proceeding.

PTO-90C (Rev. 10/03)

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Application No.

09/446,783

Applicant(s)
DESAI ETAL

Examiner

Michael G. Hartley

Art Unit

1618

~ The MAILING DATE of this communication appears on the cover sheet with the correspondence ac

fdress —

Period for Reply

A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) FROM
THE MAILING DATE OF THIS COMMUNICATION.

- Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
after SIX (6) MONTHS from the mailing date of this communication.

- If the period for reply specified above is less than thirty (30) days, a reply within the statutory minimum of thirty (30) days will be considered timely.

- If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
■ Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).

Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
earned patent term adjustment. See 37 CFR 1 .704(b).

Status

1)S Responsive to communication(s) filed on 15 April 2005 .
2a)S This action is FINAL. 2b)D This action is non-final.

3) D Since this application is in condition for allowance except for formal matters, prosecution as to the merits is

closed in accordance with the practice under Ex parte Quayle, 1935 CD. 1 1 , 453 O.G. 213.

Disposition of Claims

4) I3 Claim(s) 73-75. 103-105 and 122-133 is/are pending in the application.

4a) Of the above claim(s) is/are withdrawn from consideration.

5) D Claim(s) is/are allowed.

6) M Claim(s) 73-75. 103-105 and 122-133 is/are rejected.

7) D Claim(s) is/are objected to.

8) D Claim(s) are subject to restriction and/or election requirement.

Application Papers

9) D The specification is objected to by the Examiner.

10)D The drawing(s) filed on is/are: a)D accepted or b)D objected to by the Examiner.

Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).

Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
11 )□ The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.

Priority under 35 U.S.C. § 1 1 9

12)D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
a)D All b)D Some * c)D None of:

1 .□ Certified copies of the priority documents have been received.

2. D Certified copies of the priority documents have been received in Application No. .

3. Q Copies of the certified copies of the priority documents have been received in this National Stage

application from the International Bureau (PCT Rule 17.2(a)).
* See the attached detailed Office action for a list of the certified copies not received.

Attachment(s)

1) □ Notice of References Cited (PTO-892) 4) □ Interview Summary (PTO-413)

2) □ Notice of Drattsperson's Patent Drawing Review (PTO-948) Paper No(s)/Mail Date. .

3) ^ Information Disclosure Statement(s) (PTO-1449 or PTO/SB/08) 5) □ Notice of Informal Patent Application (PTO-152)

Paper No(s)/Mail Date 12/28/04 . 6) □ Other: .

U.S. Patent and Trademark Office
PTOL-326 (Rev. 1-04)

Office Action Summary

Part of Paper No./Mail Date 20050627

Application/Control Number: 09/446,783 Page 2

Art Unit: 1618

Response to Amendment

The amendment filed 4/15/2005 has been entered.

Response to Arguments
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for
the rejections under this section made in this Office action:
A person shall be entitled to a patent unless -

(b) the invention was patented or described in a printed publication in this or a foreign country or
in public use or on sale in this country, more than one year prior to the date of application for
patent in the United States.

Claims 73, 103, 108 and 122-132 are rejected under 35 U.S.C. 102(e) as being anticipated by
Violante (US 5,741,522), for the reasons set forth in the office action mailed 10/15/2004.

Applicant's arguments filed 4/15/2005 have been fully considered but they are not persuasive.

Applicant asserts that claim 73 distinguishes over Violante at least by requiring a dry powder or
liquid formulation of a water insoluble drug and at least one protein.

This is not found persuasive because Violante discloses an article of manufacture comprising
non-crystalline (i.e., amorphous) ultra-small particles of a drug, which are coated with a protein, see
abstract and example III. In example III, IDE porous (amorphous, solid) particles are coated with human
serum albumin (note: the IDE particles are within the scope of "drug" nanoparticles, as IDE is a CT
contrast agent, see column 7, lines 43+). Violante also discloses that the particles include various drugs,
many of which are water insoluble (i.e., wafarin, etc.), see column 9 and column 11, lines 45+. The above
argument fails to specifically discuss what is missing from Violante.

Applicant asserts that Violante is different from the claimed invention as it is drawn to water
soluble, iodinated contrast agents that contain gaseous microbubbles.

This is not found persuasive because Violante clearly discloses particles as claimed that include
a water insoluble drug (e.g., wafarin, etc.), see column 9. Further the iodinated contrast agent may be
water insoluble, see column 6, lines 60+. The particles form microbubbles when suspended in a liquid.

Application/Control Number: 09/446,783 Page 3

Art Unit: 1618

The claimed particles do not exclude particles which may form microbubbles. This argument fails to
provide a clear difference between the claimed invention and Violante, other than conclusionary
statements that they are different. What specifically is missing from Violante is unclear.

Claim Rejections - 35 USC § 103

The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness

rejections set forth in this Office action:

(a) A patent may not be obtained though the invention is not identically disclosed or described as
set forth in section 102 of this title, if the differences between the subject matter sought to be
patented and the prior art are such that the subject matter as a whole would have been obvious
at the time the invention was made to a person having ordinary skill in the art to which said
subject matter pertains. Patentability shall not be negatived by the manner in which the invention
was made.

Claims 73, 74, 104 and 133 are rejected under 35 U.S.C. 103(a) as being unpatentable over
Violante (US 5,741,522) in view of Unger (US 6,143,276), for the reasons set forth in the office action
mailed 10/15/2004.

Applicant's arguments filed 4/15/2005 have been fully considered but they are not persuasive.
Applicant repeats the arguments for Violante and asserts there is no motivation to combine the
references.

The argument for Violante is set forth above. Violante teaches that various drugs, may be
included in the particles, including anti-cancer agents. Violante and Unger are in the same field of
endeavor, e.g., ultrasound contrast agents and drug delivery particles. Violante only fails to disclose the
same drugs, e.g., anticancer drug taxol, as claimed. Unger discloses particles in the same field of
endeavor and teaches that such particles may be used as carries for various equivalent drugs, including
those claimed, e.g., that various drugs may be employed in the nanospheres, including hormones,
cyclosporin, taxol, anesthetics, etc., see columns 36-37. The motivation to combine comes from that the
particles are in the same field of endeavor and Unger teaches that various drugs, e.g., anticancer drugs,
such as, taxol, as claimed, may be delivery in such particles to optimize the type of treatment required.

Application/Control Number: 09/446,783 Page 4

Art Unit: 1618

For example, known drugs such as taxol treat specific cancers. Linger teaches these drugs benefit by
being in carriers which are similar to those of Violante.

Applicant also asserts that a combination of Violante and Unger would not arrive at the instant
invention.

This is not found persuasive because substituting the therapeutic agent (e.g., anticancer drug) of
Violante in such particles, such as, taxol, as disclosed by Unger, would arrive at the instant invention.
Applicant's assertion seems to narrowly conclude what is disclosed by the prior art.

Claim 105 is rejected under 35 U.S.C. 103(a) as being unpatentable over Violante (US
5,741 ,522) in view of Unger (US 6,143,276), as applied to claims 73, 74, 104 and 133 above, and further
in view of Jones (US 5,731 ,355), for the reasons set forth in the office action mailed 10/15/2004.

Applicant's arguments filed 4/15/2005 have been fully considered but they are not persuasive.

Jones is only being relied upon to teach that propofol is a well-known and highly successful
anesthetic, see column 1. Both Violante and Unger teach that various equivalent drugs benefit by being
incorporated into particles carriers, such as, albumin particles. The skilled artisan would have been
motivated to use various equivalent and known drugs in the carriers disclosed by Violante, such as,
propofol as disclosed by Jones to optimize the particles for the treatment desired. The use of propofol as
the drug in the particles of Violante would arrive at the instant claims.

Claims 73-75, 103-104, 108 and 122-133 are rejected under 35 U.S.C. 102(b) as being
anticipated by Desai (US 5,439,686) in view of Westesen (US 6,197,349), for the reasons set forth in the
office action mailed 10/15/2004.

Applicant's arguments filed 4/15/2005 have been fully considered but they are not persuasive.

Applicant asserts that Desai does not disclose the claimed particles, but fails to specifically
reason what is missing from Desai.

Applicant asserts that there is no motivation to combine Desai and Westesen.

Application/Control Number: 09/446,783 Page 5

Art Unit: 1618

This is not found persuasive because these references are in the same field of endeavor, e.g.,
drug-delivery particles. Desai discloses all the limitations as claimed, but is silent as to whether or not the
drug nanoparticles are amorphous.

Westesen teaches drug nanoparticles for the delivery of various drugs, taxol, etc., see abstract
and column 13. Westesen also teaches that the drug nanoparticles should be amorphous because an
amorphous state provides a higher solubility and a faster dissolution of the drug, see column 5, lines 45-
57. This is clear motivation to combine. They are in the same field of endeavor and Westesen teaches
that drug nanoparticles that the amorphous state provides a higher solubility and a faster dissolution of
the drug.

Applicant also asserts that the combination would not arrive at the invention.

This is not found persuasive because using amorphous drug in the particles of Desai would arrive
at the instant invention. A combination of references does not require that every disclosed embodiment
of the secondary reference must be used in the primary reference as appears to be asserted in the
arguments.

Claim Rejections - 35 USC §112

The following is a quotation of the second paragraph of 35 U.S.C. 112:

The specification shall conclude with one or more claims particularly pointing out and distinctly
claiming the subject matter which the applicant regards as his invention.

Claim 75 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to
particularly point out and distinctly claim the subject matter which applicant regards as the invention, for
the reasons set forth in the office action mailed 10/15/2004.

Applicant's arguments filed 4/15/2005 have been fully considered but they are not persuasive.

Applicant asserts that the albumin coating is not within the scope of surfactant, as set forth in
claim 75.

This is not found persuasive because a surfactant is defined as a surface-active agent, which
clearly encompasses albumin. Clearly a coating on a drug is within the scope of a surface-active agent.

Application/Control Number: 09/446,783 Page 6

Art Unit: 1618

A text search of the terms "surfactant" and "albumin" the same paragraph resulted in over 1000 hits in the
patent literature alone. A brief examination of these hits revealed that albumin is often defined as a
surfactant. For example, see US 3,91 1 ,138 which states "naturally occurring surfactants such as
albumin" (see col. 8, lines 5-9) or US 4914,084 which states "mixtures of the above surfactants, such as,
albumin" (col. 6, lines 19-24) or US 4,920,061 which states "Suitable surfactants include human serum
albumin" (col. 6, lines 4-10), to mention just a few. In sum, the recitation of albumin (especially as a
coating as set forth in the instant claims), is clearly within the scope of the term surfactant.

Conclusion

No claims are allowed at this time.

THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth
in 37 CFR 1.136(a).

A shortened statutory period for reply to this final action is set to expire THREE MONTHS from
the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date
of this final action and the advisory action is not mailed until after the end of the THREE-MONTH
shortened statutory period, then the shortened statutory period will expire on the date the advisory action
is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
the advisory action. In no event, however, will the statutory period for reply expire later than SIX
MONTHS from the mailing date of this final action.

Any inquiry concerning this communication or earlier communications from the examiner should
be directed to Michael G. Hartley whose telephone number is (571) 272-0616. The examiner can
normally be reached on M-Tu and Th-F, 7:30-4, Telework on Wed.

If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor,
Thurman K. Page can be reached on (571) 272-0602. The fax phone number for the organization where
this application or proceeding is assigned is 571-273-8300.

Application/Control Number: 09/446,783
Art Unit: 1618

Page 7

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6/27/2005